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Quad protocol deviation analysis. Phase III oncology trial. Site cluster shows deviation rate 14% vs network 5%. Staffing coverage reduced due to leave. Training refresh overdue by 6 months. Governance: sponsor compliance review in 2 weeks. Determine deviation cluster risk and action. Return strict JSON only.
{"deviation_cluster_risk":true,"risk_type":"staffing_and_training_gap","driver_nodes":["high deviation rate cluster","reduced staffing coverage","overdue training refresh","imminent compliance review"],"recommended_action":"training_and_staffing_intervention","action_detail":["deploy temporary staff support","conduct u...
confidence":0.88}
Staffing-training link.
PD-001
Quad protocol deviation analysis. Cardiology device trial. Deviation reports drop to zero over 4 weeks. Monitoring visit delayed. New staff onboarded without full protocol training. Governance: milestone payment tied to clean compliance. Determine risk and action. JSON only.
{"deviation_cluster_risk":true,"risk_type":"underreporting_due_to_incentive","driver_nodes":["zero deviation reporting","monitoring delay","incomplete staff training","milestone incentive pressure"],"recommended_action":"deviation_reporting_audit","action_detail":["audit source data for missed deviations","complete sta...
confidence":0.86}
Zero deviation signal.
PD-002
Quad protocol deviation analysis. Neurology trial. Fast-enrolling sites show higher dosing deviations. Staff workload exceeds targets. Training materials updated but not disseminated. Governance: DSMB safety review upcoming. Determine risk and action. JSON only.
{"deviation_cluster_risk":true,"risk_type":"workload_induced_error","driver_nodes":["dosing deviation cluster","excess staff workload","undisseminated training updates","imminent DSMB review"],"recommended_action":"workload_and_training_correction","action_detail":["redistribute workload","deliver updated training","re...
confidence":0.85}
Workload node.
PD-003
Quad protocol deviation analysis. Pulmonary trial. Visit schedule deviations rise at rural sites. Travel support reduced. Monitoring remote only. Governance: regulatory inspection possible. Determine risk and action. JSON only.
{"deviation_cluster_risk":true,"risk_type":"logistical_support_gap","driver_nodes":["visit deviation increase","reduced travel support","remote-only monitoring","inspection risk"],"recommended_action":"logistics_and_monitoring_restore","action_detail":["reinstate travel support","schedule targeted site visits","review ...
confidence":0.84}
Logistics node.
PD-004
Quad protocol deviation analysis. Metabolic trial. Conmed documentation deviations cluster at two sites. Staff turnover reported. Training logs incomplete. Governance: interim analysis approaching. Determine risk and action. JSON only.
{"deviation_cluster_risk":true,"risk_type":"turnover_documentation_gap","driver_nodes":["conmed deviation cluster","staff turnover","incomplete training logs","imminent interim analysis"],"recommended_action":"documentation_training_repair","action_detail":["update training logs","retrain staff","audit conmed entries",...
confidence":0.87}
Turnover node.
PD-005
Quad protocol deviation analysis. Vaccine trial. Deviation rates stable but severity increases. Monitoring reports late. Refresher training delayed. Governance: regulator review scheduled. Determine risk and action. JSON only.
{"deviation_cluster_risk":true,"risk_type":"severity_shift_due_to_training_lag","driver_nodes":["higher deviation severity","late monitoring reports","training delay","regulator review"],"recommended_action":"severity_audit_and_training","action_detail":["audit severe deviations","deliver refresher training","clear mon...
confidence":0.86}
Severity node.
PD-006

Clarus Clinical Quad Coupling Protocol Deviation Cluster Staffing Load Training Gap Governance Pressure v0.1

What this dataset is
This dataset tests whether a model can detect clustered protocol deviations caused by four interacting nodes.

Quad coupling nodes

  • Deviation rate or severity cluster
  • Staffing or workload pressure
  • Training gap or outdated materials
  • Governance or compliance review pressure

Input

  • One vignette

Output
Return strict JSON only.

Required output JSON keys

  • deviation_cluster_risk
  • risk_type
  • driver_nodes
  • recommended_action
  • action_detail
  • rationale
  • confidence

Files

  • data/train.csv
  • data/test.csv
  • scorer.py

Scoring

  • Required key presence
  • Risk classification
  • Risk type match
  • Driver node overlap
  • Recommended action match
  • Action detail completeness
  • Rationale length
  • Confidence within 0 to 1

Run scoring
Create JSONL
{"id":"PD-T01","output":"{...your json...}"}

Run
python scorer.py --gold_csv data/test.csv --preds_jsonl your_outputs.jsonl

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